- AstraZeneca on Tuesday provided the most detailed update yet on its efforts to develop antibody-based coronavirus drugs, which could either treat people who are infected with SARS-CoV-2 or provide short-term protection for people who have been exposed.
- The British drugmaker, already a frontrunner in the race to develop coronavirus vaccines, has licensed six antibody programs from Vanderbilt University and plans to put a combination of two into human testing within the next two months. The pharma has also signed deals with two U.S. government agencies to help advance and manufacture the drugs for clinical trials.
- AstraZeneca's projected timelines put it close behind the leaders — Eli Lilly and Regeneron — in an emerging effort to develop antibody drugs for COVID-19. Two antibodies with ties to Lilly are in Phase 1 testing, and Regeneron could follow within days. AstraZeneca joins Vir Biotechnology, Amgen, AbbVie and others who are now in the mix as well.
AstraZeneca was already a top player in the global push to develop treatments for the coronavirus, with large trials underway for an experimental vaccine and a repurposed leukemia drug, Calquence, that's being tested against some of the virus' most deadly symptoms.
But AstraZeneca could also play a role in the effort to develop engineered antibody drugs for the coronavirus, too. In April, it disclosed internal research efforts and collaborations with Vanderbilt University Medical Center and the Chinese Academy of Sciences, which both provided the company with genetic sequences for antibodies they had discovered against SARS-CoV-2. The plan, at that time, was to have some programs ready for clinical trials between July and September.
AstraZeneca is on track to meet that timeline via its deal with Vanderbilt. Two of the six antibodies licensed will form the basis of a cocktail that AstraZeneca plans to test in both treatment and preventive settings "within the next two months."
As with its COVID-19 vaccine efforts, AstraZeneca is getting a hand from the U.S. government. The Biomedical Advanced Research and Development Authority and the Defense Advanced Research Projects Agency are each pitching in to help fund manufacturing of the experimental antibodies for an early-stage trial.
BARDA has committed as much as $1.2 billion — more than any other coronavirus-related award — to develop and manufacture the vaccine AstraZeneca licensed from the University of Oxford. BARDA's grant for AstraZeneca's antibody work is much more modest, totaling just shy of $24 million.
Antibody drugs could become valuable tools in the fight against COVID-19 because of their potential to serve as treatments for sick patients or as short-term preventative medicines for those who have been exposed. Though their effects ultimately fade, antibodies can work immediately, unlike the weeks or months sometimes needed for a vaccine to provide protection.
Antibodies may also be a vaccine alternative for the elderly or those with weak immune systems, two groups for whom vaccines are less likely to work.
But antibodies almost certainly will have to be given via infusions in clinics in hospitals, limiting their use, and are complex and expensive to manufacture — a critical issue given the need for such drugs could be substantial.
"I don't know that any single company will be able to produce enough," said George Scangos, the CEO of COVID-19 antibody drug developer Vir, on a panel at the Biotechnology Industry Organization's virtual meeting on Monday.
Even large companies, like Regeneron, are looking for manufacturing help, chief scientific officer George Yancopoulos said on the panel.
There are a variety of different ways to screen for and develop antibodies, and the growing list of developers are taking different approaches. Lilly, for instance, has put two candidates in human testing that are both single engineered antibodies. Regeneron favors a cocktail approach, citing its previous, similar work with an Ebola antibody. Vir is modifying its antibodies to boost their effectiveness and staying power.
AstraZeneca appears to be going with a mix of the Regeneron and Vir approaches. It's using a cocktail, like Regeneron, but tweaking them, like Vir, to make them last longer.